Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Interpersonal Counseling and Selective Serotonin Reuptake Inhibitors(SSRI) for the treatment of Major Depression in Primary Care

Query!

Secondary ID [1]7090

Nil

Query!

Universal Trial Number (UTN)

Query!

Trial acronym

DEPICS Study

Query!

Linked study record

Query!

Health condition

Health condition(s) or problem(s) studied:

Major Depression36450

Query!

Condition category

Condition code

Mental Health3811381100

Query!

Depression

Query!

Intervention/exposure

Study type

Interventional

Query!

Description of intervention(s) / exposure

Interpersonal counseling (IPC) .IPC is a short-term highly-structured psychological intervention, derived from Interpersonal Psychotherapy (IPT) and suitable for different medical contexts.IPC is a treatment of six thirty-minute sessions, with the initial session being longer (1 hour). IPC is self-dosing: the patient determines the length of treatment, many patients feel satisfied with fewer than six sessions.In our study IPC have been adapted to accommodate needs of patients with Major Depression. In the trial the recommended number of counseling sessions is six-eight thirty-minute sessions weekly. Therapist determines if there is need of one or two additional session (6+1 or 6 + 2).IPC is delivered by residents in psychiatry, or in clinical psychology .They attended a 3-days seminar on interpersonal theory’s foundations and IPC structure and techniques; clinical examples were also discussed. Subsequently, monthly supervisions were scheduled with an IPT supervisor in order to discuss cases and to warrant the intervention’s consistency. IPC sessions were videotaped, after a signed consent was obtained from the patient, and discussed during supervisions.Patients with a HDRS score > or =13 at 2-months follow-up will receive a combined treatment including IPC and SSRI. In particular those in IPC arm begin the antidepressant therapy and will continue IPC for further 4-6 sessions.

Query!

Intervention code [1]33600

Treatment: Other

Query!

Comparator / control treatment

SSRI Antidepressants.The study evaluates the antidepressant treatment for depression as it might be delivered routinely in a clinical practice. Thus two antidepressive agents – citalopram or sertraline are used– starting at 10-20 mg for citalopram and 25-50 mg for sertraline ,orally one daily, and eventually increasing until 60 mg or 200 mg, respectively, if depressive symptomatology does not improve (consultant psychiatrist clinical evaluation). The pharmacological treatment is continued for at least 4-6 months after the individual had responded as suggested by international guideline . Consultant psychiatrist chooses between the two treatment options based on his/her personal preference and informs Primary Care Physician by letter about the suggested pharmacological treatment. Moreover he/she provided psycho-education about antidepressants and theirs side effects. Two or three subsequent visits were planned every 2-3 weeks, lasting around 15 minutes in order to evaluate patients’ compliance, clinical response and initial side effects; a specific form was used to assess adverse events. Concerning SSRI the only one modification allowed is the switch from sertraline to citalopram and vice versa.Patients with a HDRS score > or =13 at 2-months follow-up will receive a combined treatment including IPC and SSRI. In particular those in SSRI arm begin a regular 6-sessions IPC.

Query!

Control group

Active

Query!

Outcomes

Primary outcome [1]47090

The main outcome of the study is the remission of depressive symptomatology measured with Hamilton Depression Rating Scale (HDRS). The HDRS is the most widely used outcome measure in trials on depression . In detail we define remission a HDRS score less than 8.

Query!

Timepoint [1]47090

HDRS will be administered at 2,6 months and 1 year

Query!

Secondary outcome [1]79520

Secondary outcome measure is an improvement in subjective functioning measured with the Work and Social Adjustment Scale (WSAS) .It is a self-report 5-item scale used to measure functional impairment attributable to an identified problem or disorder. WSAS items investigates ability to work, home management, social leisure, private leisure, and relationships.

Query!

Timepoint [1]79520

WSAS will be administered at 2,6 months and 1 year.

Query!

Secondary outcome [2]79670

The recurrence of depressive symptoms at 12-months follow up visit.

Query!

Timepoint [2]79670

Mini International Neuropsychiatry Interview (MINI) Plus will be readministered at 12-months follow up visit.The instrument allows making a diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or International Statistical Classification of Diseases (ICD-10) criteria.

Query!

Eligibility

Key inclusion criteria

Adult patients (> or =18 years old)suffering from a Major Depression episode according to the DSM-IV criteria and having a score on Hamilton Depression Rating Scale (HDRS) > or =13 are eligible for the study.

Query!

Minimum age

18Years

Query!

Query!

Maximum age

No limit

Query!

Query!

Gender

Both males and females

Query!

Can healthy volunteers participate?

No

Query!

Key exclusion criteria

Exclusion criteria are: more than one clinically significant depressive episode in personal history, moderate to high current suicide risk, current or past episodes of mania or hypomania, psychotic disorders, cognitive impairment (Mini Mental State Examination score =27), borderline or anti-social personality disorders, current substance abuse or dependence. Furthermore, patients with poor knowledge of Italian language were excluded because they could not complete the scheduled assessments. Finally, pregnant or breastfeeding women and patients taking antidepressant drugs, mood stabilizers, antipsychotic agents or receving any kind of psychotherapy were excluded

Query!

Study design

Purpose of the study

Treatment

Query!

Allocation to intervention

Randomised controlled trial

Query!

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Allocation to treatment group is made by a research worker outside the clinical facilities where patients were enrolled assessed and treated.

Query!

Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

The present study aims to compare a brief structured psychological intervention (IPC) with the use of antidepressants (SSRI) for the treatment of major depression in primary care.The research will evaluate the efficacy of the IPC and antidepressant and it will also evaluate the efficacy of a combined therapy for non responder patients.Finally it will be tested the hypothesis that this psychological approach can reduce relapses in one year compared with those related to the use of andepressants.